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Impact of Perinatal Exposure to Non-caloric Sweeteners on Food Preferences and Weight Gain in the First Year of Life

31. mai 2019 oppdatert av: Martin Gotteland, University of Chile

Determination of Perinatal Exposure to Non-caloric Sweeteners. Implications for the Development of Preferences for Sweet Taste, and Weight Gain During the First Year of Life

During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile. This situation has reached a point where it is currently difficult to find sugary foods without NCSs. As a result, the voluntary and involuntary consumption of these additives is growing significantly in the population, increasing the risk of exceeding the acceptable daily intake (ADI), especially for children. This situation is worrying as recent evidence suggests that NCSs are not inert in the body and can trigger adverse metabolic effects. For example, the consumption of beverages with NCSs has been shown to favor the development of obesity and type-2 diabetes in children and adults, and a recent study reported that the intake of NCSs during pregnancy was associated with a greater weight gain of the child at one year. It is likely that certain NCSs pass into the amniotic fluid and that the fetus is exposed to some of these compounds during pregnancy. This situation would persist in the infant through breast milk, as some studies detected sucralose and acesulfame-K in this fluid, even in mothers who claimed not to consume them. However, the real impact of NCS exposure during the neonatal period on the child health has been few studied. Therefore, the aim of this study is to determine the concentration of NCSs in samples of amniotic liquid and breastmilk and to correlate these data with the NCS intake by the mothers. Mothers/children will be classified in quintiles according to the results obtained. In the children from quintiles 1 and 5, we will also study whether neonatal exposure to NCSs may affect the sweet taste threshold and the preferences for this taste, the levels of salivary insulin and the weight gain in the first year. Breastmilk microbiota and child fecal microbiota will be also evaluated.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Forventet)

315

Kontakter og plasseringer

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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

315 dyades mother/child recruited at the San Jose Hospital Maternity

Beskrivelse

Inclusion Criteria:

  • Women with at least 36 weeks of gestation
  • Spanish-speaking
  • Elective cesarean delivery

Exclusion Criteria:

  • Multiple pregnancy
  • Type-2 diabetes
  • Intelectual disability
  • Presence of infectious disease compatible with chorio-amnionitis or immunosupression
  • Newborns with serious pathologies affecting their growth

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mothers with breastmilk NCSs
Tidsramme: One month post-partum
Proportion of mothers with detectable NCSs in their breastmilk
One month post-partum

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mothers with amniotic liquid NCSs
Tidsramme: At delivery
Proportion of mothers with detectable NCSs in their amniotic liquid
At delivery
Consumption of NCSs by the mothers
Tidsramme: At recruitment (in the last month of pregnancy) and at 1 mont post-partum
Daily intake (mg/d) of sucralose, acesulfame-K, cyclamate, saccharin and stevia evaluated through a validated consumer trend survey
At recruitment (in the last month of pregnancy) and at 1 mont post-partum
Pregnancy complications
Tidsramme: At delivery
Percentages of mothers with preclampsia, hypertension, gestacional diabetes, infections, or preterm labor
At delivery
Breastmilk concentrations of NCSs
Tidsramme: One month post-partum
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in breastmilk samples
One month post-partum
Amniotic liquid concentrations of NCSs
Tidsramme: At delivery
Concentrations of sucralose, acesulfame-K, cyclamate, saccharin, steviol in amniotic liquid samples
At delivery
Sweet taste of breastmilk
Tidsramme: One month post-partum
Intensity (arbitrary units) of sweet taste in breast milk samples, as detected by e-tongue
One month post-partum
Sweet taste of amniotic liquid
Tidsramme: At delivery
Intensity (arbitrary units) of sweet taste in amniotic liquid samples, as detected by e-tongue
At delivery
Threshold of sweet taste in children
Tidsramme: 6 months
Determination of sweet taste threshold (lower concentration of sucrose detected) in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that received
6 months
Food preferences in children
Tidsramme: At 6 month of age
Food consumption in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that receiveded,through a validated consumer trend survey
At 6 month of age
Salivary insulin in children
Tidsramme: 6 months
Salivary concentration of insulin (pg/ml) in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
6 months
Infant gain weight
Tidsramme: At 12 months
Changes in weight (kg) during the first year of life
At 12 months
Breast milk microbiota diversity
Tidsramme: At one month post-partum
Intraindividual diversity of the breastmilk microbiota evaluated by Shannon index in samples from quintiles 1 and 5 of classification according to their NCS concentrations
At one month post-partum
Breast milk microbiota composition
Tidsramme: At one month post-partum
Relative abundancies of the different bacterial taxa from the breastmilk microbiota, detected by high throughput sequencing, in samples from quintiles 1 and 5 of classification according to their NCS concentrations
At one month post-partum
Fecal microbiota diversity in children
Tidsramme: At six months post-partum
Intraindividual diversity of the fecal microbiota, evaluated by Shannon index, in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
At six months post-partum
Fecal microbiota composition in children
Tidsramme: At six months post-partum
Relative abundancies of the different bacterial taxa from the fecal microbiota, detected by high throughput sequencing, in children from quintiles 1 and 5 of classification according to the concentrations of NCS in breast milk that they received
At six months post-partum
Polymorphism of sweet taste receptor in children
Tidsramme: At six months post-partum
Proportions of children presenting the different polymorphisms on the sweet taste receptor gene.
At six months post-partum

Samarbeidspartnere og etterforskere

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Etterforskere

  • Hovedetterforsker: Veronica Sambra, MaSc, University of Chile
  • Hovedetterforsker: Sandra Lopez, PhD, University of Chile
  • Hovedetterforsker: Paola Caceres, MaSc, University of Chile
  • Hovedetterforsker: Francisco Perez, PhD, University of Chile
  • Hovedetterforsker: Edgar Pastene, PhD, University of Concepción

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. juli 2019

Primær fullføring (Forventet)

1. juli 2020

Studiet fullført (Forventet)

1. juli 2021

Datoer for studieregistrering

Først innsendt

30. mai 2019

Først innsendt som oppfylte QC-kriteriene

31. mai 2019

Først lagt ut (Faktiske)

3. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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